Viewing Study NCT03974932

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Ignite Creation Date: 2025-12-24 @ 9:54 PM
Ignite Modification Date: 2026-02-22 @ 5:22 PM
Study NCT ID: NCT03974932
Status: COMPLETED
Last Update Posted: 2023-08-31
First Post: 2019-06-03
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cquaratino-baker@herontx.com', 'phone': '1-800-767-0524', 'title': 'Clinical Operations', 'organization': 'Heron Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.', 'description': 'At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 56, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 15, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Incision site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Incision site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Incision site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Incision site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Postoperative hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}], 'seriousEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '155.57', 'spread': '95.651', 'groupId': 'OG000'}, {'value': '185.27', 'spread': '86.898', 'groupId': 'OG001'}, {'value': '161.36', 'spread': '86.627', 'groupId': 'OG002'}, {'value': '126.59', 'spread': '118.431', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 through 48 hours', 'description': 'The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.', 'unitOfMeasure': 'pain intensity score*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean AUC of VAS Scores.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '277.03', 'spread': '164.004', 'groupId': 'OG000'}, {'value': '319.81', 'spread': '158.746', 'groupId': 'OG001'}, {'value': '276.87', 'spread': '146.578', 'groupId': 'OG002'}, {'value': '216.18', 'spread': '206.164', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.', 'unitOfMeasure': 'pain intensity score*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean AUC of the NRS of Pain Intensity at Rest (NRS-R).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '309.89', 'spread': '155.289', 'groupId': 'OG000'}, {'value': '355.20', 'spread': '161.377', 'groupId': 'OG001'}, {'value': '311.00', 'spread': '136.714', 'groupId': 'OG002'}, {'value': '245.00', 'spread': '200.369', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain". NRS scores are measured at rest.', 'unitOfMeasure': 'pain intensity score*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Severe Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'title': '24 Hours', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': '72 Hours', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'Severe Pain defined as a VAS score ≥7.5 cm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [MME]).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.40', 'spread': '23.229', 'groupId': 'OG000'}, {'value': '31.50', 'spread': '24.907', 'groupId': 'OG001'}, {'value': '23.40', 'spread': '14.484', 'groupId': 'OG002'}, {'value': '17.62', 'spread': '22.167', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'unitOfMeasure': 'MME, morphine milligram equivalency', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Are Opioid-free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 Hours to Day 11', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Are Opioid-free Through 72 Hours Who Remain Opioid-free Through Day 11.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours through Day 11', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Time to First Opioid Rescue Medication.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.12', 'groupId': 'OG000', 'lowerLimit': '4.27', 'upperLimit': '8.25'}, {'value': '5.63', 'groupId': 'OG001', 'lowerLimit': '2.12', 'upperLimit': '19.48'}, {'value': '9.96', 'groupId': 'OG002', 'lowerLimit': '4.18', 'upperLimit': '15.90'}, {'value': '12.76', 'groupId': 'OG003', 'lowerLimit': '5.80', 'upperLimit': '47.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through 72 hours', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who do Not Receive an Opioid Prescription at Discharge.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who do Not Receive an Opioid Prescription Between Discharge and the Day 11 Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours through Day 11', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving a Score of "Good" or Better (>1) Pain Control Based on Patient Global Assessment (PGA).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'title': '24 Hours', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': '72 Hours', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours, 48 hours, 72 hours, Day 11', 'description': "Patient's Global Assessment (PGA) of pain control is a 4-point scale in which subjects rate how well their pain has been controlled (0 = Poor; 1 = Fair; 2 = Good; 3 = Excellent).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Time to First Ambulation Postsurgery.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.66', 'groupId': 'OG000', 'lowerLimit': '18.48', 'upperLimit': '23.43'}, {'value': '23.20', 'groupId': 'OG001', 'lowerLimit': '6.08', 'upperLimit': '54.62'}, {'value': '26.72', 'groupId': 'OG002', 'lowerLimit': '24.37', 'upperLimit': '29.60'}, {'value': '20.58', 'groupId': 'OG003', 'lowerLimit': '5.83', 'upperLimit': '23.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Unable to Participate in Each Rehabilitation Session Because of Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who First Achieve an MPADSS Score ≥9.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'title': 'Through 2 Hours', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Through 4 Hours', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Through 6 Hours', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Through 8 Hours', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Through 12 Hours', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Through 24 Hours', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Through 36 Hours', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Through 48 Hours', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'Through 60 Hours', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'Through 72 Hours', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24, hours, 36 hours, 48 hours, 60 hours, 72 hours', 'description': 'Subjects were assessed for readiness for discharge using the Modified Post-Anesthesia Discharge Scoring System (MPADSS) that assesses 5 clinical variables: vital signs, ambulation, nausea/vomiting, pain, and surgical bleeding, each on a 3-point scale of 0, 1, or 2 with 0 being the worst score and 2 being the best score. Subjects with an MPADSS score of 9 or 10 were considered ready for discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Who Are Discharged Home vs to a Skilled Nursing Facility.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'description': 'Number Analyzed represents Subjects who were discharged home.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Overall Benefit of Analgesia Score (OBAS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'title': '24 Hours', 'categories': [{'measurements': [{'value': '6.5', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '6.36', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '3.24', 'groupId': 'OG002'}, {'value': '5.9', 'spread': '3.45', 'groupId': 'OG003'}]}]}, {'title': '48 Hours', 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '2.89', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '2.57', 'groupId': 'OG003'}]}]}, {'title': '72 Hours', 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '1.88', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '2.29', 'groupId': 'OG003'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '2.08', 'groupId': 'OG002'}, {'value': '4.9', 'spread': '2.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours, 48 hours, 72 hours, Day 11', 'description': 'Subjects were questioned about their overall benefit of analgesia. Overall benefit of analgesia score (OBAS) assesses current pain at rest, vomiting, itching, sweating, freezing, dizziness, and overall satisfaction with postoperative pain during the previous 24 hours. To calculate the OBAS score, each of the subscale scores (0=minimum; 4=maximum) are summed for a combined OBAS score. Possible scores could range from 0 to 28 with a lower score indicating greater benefit.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Total TSQM-9 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'title': 'Global Satisfaction Domain - 72 Hours', 'categories': [{'measurements': [{'value': '86.9', 'spread': '15.53', 'groupId': 'OG000'}, {'value': '77.0', 'spread': '22.62', 'groupId': 'OG001'}, {'value': '89.3', 'spread': '14.75', 'groupId': 'OG002'}, {'value': '86.8', 'spread': '13.57', 'groupId': 'OG003'}]}]}, {'title': 'Effectiveness Doman - 72 Hours', 'categories': [{'measurements': [{'value': '86.4', 'spread': '18.09', 'groupId': 'OG000'}, {'value': '80.2', 'spread': '20.52', 'groupId': 'OG001'}, {'value': '84.0', 'spread': '14.61', 'groupId': 'OG002'}, {'value': '81.9', 'spread': '15.39', 'groupId': 'OG003'}]}]}, {'title': 'Convenience Domain - 72 Hours', 'categories': [{'measurements': [{'value': '90.1', 'spread': '12.03', 'groupId': 'OG000'}, {'value': '84.5', 'spread': '17.18', 'groupId': 'OG001'}, {'value': '93.1', 'spread': '13.07', 'groupId': 'OG002'}, {'value': '86.9', 'spread': '16.45', 'groupId': 'OG003'}]}]}, {'title': 'Global Satisfaction Domain - Day 11', 'categories': [{'measurements': [{'value': '78.0', 'spread': '22.39', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '27.27', 'groupId': 'OG001'}, {'value': '72.8', 'spread': '21.22', 'groupId': 'OG002'}, {'value': '82.9', 'spread': '18.16', 'groupId': 'OG003'}]}]}, {'title': 'Effectiveness Doman - Day 11', 'categories': [{'measurements': [{'value': '76.3', 'spread': '21.18', 'groupId': 'OG000'}, {'value': '69.4', 'spread': '29.13', 'groupId': 'OG001'}, {'value': '69.4', 'spread': '29.13', 'groupId': 'OG002'}, {'value': '67.0', 'spread': '24.80', 'groupId': 'OG003'}]}]}, {'title': 'Convenience Domain - Day 11', 'categories': [{'measurements': [{'value': '90.1', 'spread': '12.03', 'groupId': 'OG000'}, {'value': '86.9', 'spread': '15.50', 'groupId': 'OG001'}, {'value': '80.9', 'spread': '15.31', 'groupId': 'OG002'}, {'value': '90.6', 'spread': '12.24', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours through Day 11', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM-9) contains 9 items assessing Effectiveness, Convenience, and Global Satisfaction domains. Responses to items are rated on a 5-point or 7-point rating scale. Scores for each domain are computed by adding the TSQM items in each domain and then transforming the values in to a composite score ranging from 0 to 100, with higher scores representing higher satisfaction.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'title': 'Bupivacaine', 'categories': [{'measurements': [{'value': '566', 'spread': '273', 'groupId': 'OG000'}, {'value': '534', 'spread': '175', 'groupId': 'OG001'}, {'value': '742', 'spread': '268', 'groupId': 'OG002'}, {'value': '851', 'spread': '288', 'groupId': 'OG003'}]}]}, {'title': 'Meloxicam', 'categories': [{'measurements': [{'value': '238', 'spread': '96.8', 'groupId': 'OG000'}, {'value': '247', 'spread': '89.0', 'groupId': 'OG001'}, {'value': '251', 'spread': '104', 'groupId': 'OG002'}, {'value': '385', 'spread': '161', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time of Occurrence of Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'OG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'classes': [{'title': 'Bupivacaine', 'categories': [{'measurements': [{'value': '21.05', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '49.83'}, {'value': '20.54', 'groupId': 'OG001', 'lowerLimit': '3.98', 'upperLimit': '37.27'}, {'value': '20.14', 'groupId': 'OG002', 'lowerLimit': '2.10', 'upperLimit': '37.02'}, {'value': '22.48', 'groupId': 'OG003', 'lowerLimit': '8.05', 'upperLimit': '48.63'}]}]}, {'title': 'Meloxicam', 'categories': [{'measurements': [{'value': '47.13', 'groupId': 'OG000', 'lowerLimit': '18.38', 'upperLimit': '49.83'}, {'value': '58.58', 'groupId': 'OG001', 'lowerLimit': '23.65', 'upperLimit': '73.28'}, {'value': '37.17', 'groupId': 'OG002', 'lowerLimit': '20.35', 'upperLimit': '71.43'}, {'value': '48.58', 'groupId': 'OG003', 'lowerLimit': '20.85', 'upperLimit': '73.37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '72 hours', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'FG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'FG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'FG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Subjects in Cohort 1 and Cohort 2 received the same Assigned Intervention (ie, HTX-011 400 mg/12 mg + celecoxib-containing MMA regimen) and results are pooled for the purpose of this Results Section.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 and Cohort 2 (Pooled)', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.'}, {'id': 'BG001', 'title': 'Cohort 3: Group A', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.'}, {'id': 'BG002', 'title': 'Cohort 3: Group B', 'description': 'HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.'}, {'id': 'BG003', 'title': 'Cohort 4', 'description': 'HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '9.64', 'groupId': 'BG000'}, {'value': '62.4', 'spread': '8.88', 'groupId': 'BG001'}, {'value': '66.8', 'spread': '9.81', 'groupId': 'BG002'}, {'value': '69.0', 'spread': '8.82', 'groupId': 'BG003'}, {'value': '65.1', 'spread': '9.64', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The 1 participant in Cohort 2 listed as 'Unknown or Not Reported' includes Puerto Rican.", 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-02', 'size': 825584, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-17T10:52', 'hasProtocol': True}, {'date': '2021-07-01', 'size': 563734, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-17T10:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-08', 'studyFirstSubmitDate': '2019-06-03', 'resultsFirstSubmitDate': '2021-12-17', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-08', 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).', 'timeFrame': '12 through 48 hours', 'description': 'The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.'}], 'secondaryOutcomes': [{'measure': 'Mean AUC of VAS Scores.', 'timeFrame': '72 hours', 'description': 'The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.'}, {'measure': 'Mean AUC of the NRS of Pain Intensity at Rest (NRS-R).', 'timeFrame': '72 hours', 'description': 'Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain". NRS scores are measured at rest.'}, {'measure': 'Percentage of Subjects With Severe Pain.', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'Severe Pain defined as a VAS score ≥7.5 cm.'}, {'measure': 'Mean Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [MME]).', 'timeFrame': '72 hours'}, {'measure': 'Percentage of Subjects Who Are Opioid-free', 'timeFrame': '72 Hours to Day 11'}, {'measure': 'Percentage of Subjects Who Are Opioid-free Through 72 Hours Who Remain Opioid-free Through Day 11.', 'timeFrame': '72 hours through Day 11'}, {'measure': 'Median Time to First Opioid Rescue Medication.', 'timeFrame': 'Through 72 hours'}, {'measure': 'Percentage of Subjects Who do Not Receive an Opioid Prescription at Discharge.', 'timeFrame': '72 hours'}, {'measure': 'Percentage of Subjects Who do Not Receive an Opioid Prescription Between Discharge and the Day 11 Visit.', 'timeFrame': '72 hours through Day 11'}, {'measure': 'Percentage of Subjects Achieving a Score of "Good" or Better (>1) Pain Control Based on Patient Global Assessment (PGA).', 'timeFrame': '24 hours, 48 hours, 72 hours, Day 11', 'description': "Patient's Global Assessment (PGA) of pain control is a 4-point scale in which subjects rate how well their pain has been controlled (0 = Poor; 1 = Fair; 2 = Good; 3 = Excellent)."}, {'measure': 'Median Time to First Ambulation Postsurgery.', 'timeFrame': '72 hours'}, {'measure': 'Percentage of Subjects Unable to Participate in Each Rehabilitation Session Because of Pain.', 'timeFrame': '72 hours'}, {'measure': 'Percentage of Subjects Who First Achieve an MPADSS Score ≥9.', 'timeFrame': '2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24, hours, 36 hours, 48 hours, 60 hours, 72 hours', 'description': 'Subjects were assessed for readiness for discharge using the Modified Post-Anesthesia Discharge Scoring System (MPADSS) that assesses 5 clinical variables: vital signs, ambulation, nausea/vomiting, pain, and surgical bleeding, each on a 3-point scale of 0, 1, or 2 with 0 being the worst score and 2 being the best score. Subjects with an MPADSS score of 9 or 10 were considered ready for discharge.'}, {'measure': 'Percentage of Subjects Who Are Discharged Home vs to a Skilled Nursing Facility.', 'timeFrame': '72 hours', 'description': 'Number Analyzed represents Subjects who were discharged home.'}, {'measure': 'Mean Overall Benefit of Analgesia Score (OBAS).', 'timeFrame': '24 hours, 48 hours, 72 hours, Day 11', 'description': 'Subjects were questioned about their overall benefit of analgesia. Overall benefit of analgesia score (OBAS) assesses current pain at rest, vomiting, itching, sweating, freezing, dizziness, and overall satisfaction with postoperative pain during the previous 24 hours. To calculate the OBAS score, each of the subscale scores (0=minimum; 4=maximum) are summed for a combined OBAS score. Possible scores could range from 0 to 28 with a lower score indicating greater benefit.'}, {'measure': 'Mean Total TSQM-9 Score', 'timeFrame': '72 hours through Day 11', 'description': 'The Treatment Satisfaction Questionnaire for Medication (TSQM-9) contains 9 items assessing Effectiveness, Convenience, and Global Satisfaction domains. Responses to items are rated on a 5-point or 7-point rating scale. Scores for each domain are computed by adding the TSQM items in each domain and then transforming the values in to a composite score ranging from 0 to 100, with higher scores representing higher satisfaction.'}, {'measure': 'Maximum Concentration (Cmax)', 'timeFrame': '72 hours'}, {'measure': 'Time of Occurrence of Maximum Concentration (Tmax)', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'postoperative pain', 'multimodal analgesia'], 'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is scheduled to undergo primary unilateral TKA under spinal anesthesia.\n* Has not previously undergone TKA in either knee.\n* Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.\n* Is able to walk at least 20 feet with optional use of a 4-legged walker for balance.\n* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or is at least 2 years post-menopausal; or is in a monogamous relationship with a partner who is surgically sterile; or using acceptable contraceptives.\n\nExclusion Criteria:\n\n* Has a planned concurrent surgical procedure.\n* Has other pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.\n* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.\n* Using or expected to use Factor IX Complex or anti-inhibitor coagulant concentrates during the study.\n* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.\n* Has taken NSAIDs within 10 days prior to the scheduled surgery with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.\n* Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).\n* Has been administered bupivacaine within 5 days prior to the scheduled surgery.\n* Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.\n* Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.\n* Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.\n* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.\n* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.\n* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.\n* Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.\n* Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments.\n* Has acquired defective color vision or acute gastrointestinal ulcers, either of which could interfere with scheduled study medications.\n* Has any chronic neuromuscular deficit of either femoral nerve function or thigh musculature.\n* Has any chronic condition or disease that would compromise neurological or vascular assessments.\n* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.\n* Has undergone 3 or more surgeries within 12 months.\n* Has a body mass index (BMI) \\>39 kg/m2.'}, 'identificationModule': {'nctId': 'NCT03974932', 'briefTitle': 'Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heron Therapeutics'}, 'officialTitle': 'A Phase 3b, Open-Label Study of HTX-011 as Part of a Scheduled Non-Opioid Multimodal Analgesic Regimen in Subjects Undergoing Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'HTX-011-306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'HTX-011 + MMA', 'interventionNames': ['Drug: HTX-011', 'Drug: Ibuprofen', 'Drug: Acetaminophen', 'Drug: Celecoxib', 'Device: Luer Lock Applicator']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'HTX-011 + MMA', 'interventionNames': ['Drug: HTX-011', 'Drug: Ibuprofen', 'Drug: Acetaminophen', 'Drug: Celecoxib', 'Device: Luer Lock Applicator']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'HTX-011 + MMA', 'interventionNames': ['Drug: Ibuprofen', 'Drug: Acetaminophen', 'Drug: Celecoxib', 'Drug: +/- Bupivacaine HCl', 'Device: Luer Lock Applicator', 'Drug: HTX-011']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'HTX-011 + MMA', 'interventionNames': ['Drug: HTX-011', 'Drug: Ibuprofen', 'Drug: Acetaminophen', 'Device: Luer Lock Applicator']}], 'interventions': [{'name': 'HTX-011', 'type': 'DRUG', 'description': 'Dual-acting local anesthetic. Dose 1.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 4']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': 'NSAID.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'description': 'Analgesic.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}, {'name': 'Celecoxib', 'type': 'DRUG', 'description': 'NSAID.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': '+/- Bupivacaine HCl', 'type': 'DRUG', 'description': 'Local anesthetic.', 'armGroupLabels': ['Cohort 3']}, {'name': 'Luer Lock Applicator', 'type': 'DEVICE', 'description': 'Applicator for instillation.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}, {'name': 'HTX-011', 'type': 'DRUG', 'description': 'Dual-acting local anesthetic. Dose 2.', 'armGroupLabels': ['Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Helen Keller Hospital', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'Phoenix Clinical Research, LLC', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '45417', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Midwest Clinical Research Center, LLC', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'First Surgical Hospital', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Plano Surgical Hospital', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials, LLC.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heron Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}